Registration Dossier
Registration Dossier
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EC number: 211-309-7 | CAS number: 637-92-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethoxy-2-methylpropane
- EC Number:
- 211-309-7
- EC Name:
- 2-ethoxy-2-methylpropane
- Cas Number:
- 637-92-3
- Molecular formula:
- C6H14O
- IUPAC Name:
- 2-ethoxy-2-methylpropane
- Details on test material:
- - Name of test material (as cited in study report): ETBE
- Physical state: colourless liquid
- Analytical purity: 95.8%
- Lot/batch No.: 93050601
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ESD
- Age at study initiation: about 3 months old
- Weight at study initiation: 2.0 - 3.0 kg
- Housing: individually
- Diet: 150 g/animal/day
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +- 3
- Humidity (%): >45
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml, 100 %
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours, 7 days
- Number of animals:
- 3 males
- Details on study design:
- 0.5 ml ETBE was applied to a gauze pad (2.5 x 2.5 cm) which was held in contact with clipped healthy skin under a semi-occlusive dressing for 4 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24+48+72 hr
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24+48+72 hr
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Under the conditions of the test, ETBE was not irritating to the skin.
- Other effects:
- One animal showed slight desquamation at the application site on day 7.
Applicant's summary and conclusion
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